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Oruka Therapeutics builds long-acting psoriasis case as ORKA-001 clearance deepens without redosing
ORKA-001 reaches 71.4% complete psoriasis clearance without redosing as Oruka Therapeutics advances its long-acting biologic toward Phase 3.
Sefaxersen moves toward regulatory talks after Roche delivers positive Phase III IgAN result
Roche’s sefaxersen hits its Phase III IgAN endpoint as the company eyes regulatory talks in a fast-growing kidney disease market.
ADARx IPO grows to $446m as RNA drug developer targets Nasdaq debut
ADARx Pharmaceuticals has priced an enlarged U.S. IPO at $17 a share, generating about $446.3 million before expenses, while AbbVie plans a concurrent investment that would give it roughly 4.9% ownership.
Mesoblast rises as FDA clears new commercial potency assay for Ryoncil
Mesoblast Limited shares rose after the United States Food and Drug Administration approved an additional potency assay for commercial Ryoncil manufacturing, strengthening quality controls as the Australian biotechnology company scales its first marketed cell therapy.
Eli Lilly signs InnoCare drug discovery deal worth up to $3.35bn
The partnership covers as many as five drug targets, with most of the headline value dependent on development and commercial milestones.
Roquette revenue rises 9% as IFF Pharma Solutions acquisition boosts healthcare portfolio
Roquette EBITDA rose 18% to €337 million as pharma growth, cost savings and lower debt offset continued pressure in starch markets.
Lisata Therapeutics buys Marea with $225m PIPE as old holders fall to 2.39%
Lisata Therapeutics, Inc. has acquired Marea Therapeutics, Inc. alongside a $225 million private placement, leaving pre-transaction Lisata Therapeutics shareholders with only about 2.39% of the fully diluted company.
North Immunology lands Nasdaq route and $180m financing through Aethlon merger
Aethlon Medical, Inc. is merging with North Immunology, Inc. in a transaction backed by a $180 million private placement, but existing Aethlon Medical shareholders are expected to own only about 4.75% of the combined company.
Ultragenyx adds sixth FDA-approved product as FAYUVI targets Sanfilippo syndrome
Ultragenyx Pharmaceutical Inc. has secured full FDA approval for FAYUVI, a $3.95 million one-time gene therapy for Sanfilippo syndrome type A, giving the rare-disease company a major commercial catalyst weeks after another program wiped 44% from its share price.
Johnson & Johnson’s Caplyta delivers rapid Phase III bipolar mania response
The once-daily medicine reduced manic symptoms by significantly more than placebo and doubled the clinical response rate, advancing a potential new indication for a drug acquired with Intra-Cellular Therapies.